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510(k) K991388

Device
ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M
Applicant
PACIFIC ANDROLOGY, INC.
510(k) number
K991388
Product code
MQH  
Decision
Substantially Equivalent (SESE)
Decision date
1999-09-13
Date received
1999-04-21
Regulation
884.6130
Classification name
Microtools, Assisted Reproduction (pipettes)
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GREG HOLLAND
Address
3722 Ave. Sausalito Irvine CA US 92606 92606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MQH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250838Denudation PipettesGuangzhou Pinzhi Medical Device Co., Ltd.2025-07-03
K192146V-DENUPETVitromed GmbH2020-01-28
K161275EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripResearch Instruments Limited2017-01-23
K152581LifeGlobal Micro TipsLife Global Group, LLC2016-04-11
K151018Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteCook Incorporated2016-01-08
K150748Flexipet Denuding Pipette, Flexipet Manipulation PipetteCook Incorporated2015-12-18
K133257BIOPSY PIPETTESResearch Instruments , Ltd.2014-05-16
K102480INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HAJieying Laboratory, Inc.2011-04-19
K092554BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTESSunlight Medical, Inc.2010-04-30
K072600INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTESSunlight Medical, Inc.2008-05-19
K041435THE STRIPPER PGDMid-Atlantic Diagnostics, Inc.2004-09-29
K041562CRYOTIPIrvine Scientific Sales Co., Inc.2004-08-09
K033903MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,Cook Urological, Inc.2004-01-16
K033904PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)Cook Urological, Inc.2004-01-16
K024302PRECISION CAPILLARIES FOR MICROMANIPULATIONBrinkmann Instruments, Inc.2003-02-19

Legacy Summary#

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FDA Review#

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